At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 517 enrolled
Drug / intervention
sitagliptin phosphate (+) metformin hydrochloride +1 moredrug
Likely dose
sitagliptin phosphate (+) metformin hydrochloride 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating sitagliptin phosphate (+) metformin hydrochloride and Comparator: pioglitazone for Type 2 Diabetes Mellitus. Completed, enrolled 517 participants.
Detailed Summary
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartJan 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedSep 21, 2007
Enrollment StartJan 26, 2008
Primary CompletionOct 23, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.8 years ago
Interventions
sitagliptin phosphate (+) metformin hydrochloridedrug
sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period
Comparator: pioglitazonedrug
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.